Inflatable dental impression tray and mixing tip

ABSTRACT

An inflatable dental tray for creating a dental impression. The tray is inflated for retention of an impression material that solidifies after a dental structure has been impressed therein. The inflatable tray can be configured for various inflation methods and in various shapes to form full or partial impressions. In one aspect of the invention the tray is inflated with impression material that flows from apertures forming a buildup. In another embodiment, the inflatable tray has a rigid support. Various additional inventive aspects include an exterior filled inflated tray and fill tubes that provide for proper mixing of impression material.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation-in-part of copending application Ser. No. 10/099,549 filed on Mar. 13, 2002, which is a continuation of Ser. No. 09/596,296, filed on Jun. 16, 2000, now U.S. Pat. No. 6,364,661 which is incorporated herein by reference. This application also claims priority from U.S. provisional application serial No. 60/369,408 filed on Apr. 1, 2002, incorporated herein by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0002] Not Applicable

INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC

[0003] Not Applicable

BACKGROUND OF THE INVENTION

[0004] 1. Field of the Invention

[0005] This invention pertains generally to dental impression trays and more particularly to an inflatable dental impression tray and tips for use in mixing multi-part dental impression material.

[0006] 2. Description of Related Art

[0007] Many dental procedures require that accurate castings be made of dental surfaces, gums in the case of maxillary casts, or upon a patient presenting an edentulous situation. Traditional dental castings are made by the application by the dental practitioner of one or more layers of a liquid dental impression material to a retention shell called a tray. The liquid dental impression material is highly viscous and quick setting and typically applied as a gel or a mousse. The impression material generally is formed from two constituent components that react when mixed to facilitate quick setting. A dental impression tray loaded with the impression material is inserted into the mouth of a patient and the patient bites down on the material and tray and holding the teeth in that position until the impression material has sufficiently solidified, at which time the tray and dental impression are removed. Once removed from the patient's mouth, the tray with the solidified material contains an impression of the dental surfaces.

[0008] Impression trays in current use are typically fabricated from a molded synthetic plastic or resin or from a metal. These impression trays are typically large “U-shaped” devices for taking a full arch impression which spans the entire dental area of the upper or lower jaw, or partial arch trays which are used for taking impressions over a smaller dental areas, such as a quadrant which spans either a left or right half of a full arch (LR, LL, UR, UL). In either case, these shell form trays generally contain some form of inner and outer rigid or semi-rigid sidewall between which the impression material is retained. The trays generally are constructed of sufficient size so that the positioning of the sidewalls accommodates a variety of bite pattern shapes. Due largely to this one size fits all approach, the tray typically requires a large amount of impression material for proper loading.

[0009] The elastomeric impression materials currently in use fall within seven major groups. These general groupings include: 1) reversible hydrocolloids; 2) irreversible hydrocolloids such as alginate, 3) addition reaction silicones such as polyvinyl siloxanes; 4) condensation reaction silicones; 5) polyethers; 6) rubber based polysulfides, and 7) light-cured impression materials. A miscellaneous group of impression materials include polyester, wax, silicon, polyacrylics, and putties. Impression materials exhibit varying levels of viscosity and curing times.

[0010] A few tray manufacturers have provided anatomical sets of reusable bite trays having a variety of wall heights and spacing, so that a smaller tray may be chosen that has sidewall positions that more accurately reflects the size, shape, and bite pattern of the patient. Yet, in either case, the sidewalls that retain the impression material within the tray can interfere with tissue/bony interfaces, or anomalies, which prevents proper insertion as they often do not properly match the shape of the mouth of the patient. Current dental techniques and devices uniformly teach the use of these shell-like trays into which a two-part impression material is applied before making the dental impression. Various dual-chamber syringes and tubes are used for the dispensing and mixing of the two parts of the impression material. In addition cybernetic mixing units such as Penta™ by ESPE Mix and Mixstar™ by DMG have also been used for mixing and dispensing impression material.

[0011] The dental practitioner is required to rapidly load the area within the tray with unsolidified impression material by placing it between the inner and outer impression material retention sidewalls before the impression material begins to solidify. The tray containing the impression material is inserted into the mouth of the patient, adjusted into position, and the patient is directed to bite down and hold their position, so as to get a good impression.

[0012] Alternatively the dental practitioner may hold the tray that contains the solidifying impression material in place while the material sets. Due to their size and construction, dental impression trays are comparatively expensive; therefore many impression trays are made to be reusable. Unfortunately, the process of recycling a dental tray requires the removal of all hardened impression material followed by sterilization, which is typically performed within an autoclave. The sterilized tray must then be protected from contamination until reuse. Disposable clam-shell trays have also been manufactured, however, their high unit cost has traditionally been a detractor. Furthermore, in utilizing either disposable or reusable trays, the dental practitioner is required to store an assortment of these trays under antiseptic conditions.

[0013] The drawbacks inherent in current tray designs have caused many in the industry to experiment with variations of these standard dental impression trays. Recently, trays have been introduced which include an injection nozzle so that an otherwise typical shell type impression tray can be filled more easily with impression material. The impression material is still retained as in a typical shell arrangement with rigid sidewalls utilized for retention of the impression material.

[0014] Other tray varieties have been introduced including trays that contain a plastic or metal perimeter upon which a fabric material is suspended so that a layer of impression material may be built-up on the fabric. However, the principal drawbacks in the use of these practitioner-filled dental impression trays, with their rigid material retention sidewalls, still remains, and the practitioner is left with the choice of using expensive disposable trays, or spending a great deal of time to clean up and recycle used trays.

[0015] The task of finding a properly fitting tray with sidewalls compatible with the oral contours of the patient can be inconvenient for the dental practitioner and uncomfortable for the patient. While in addition, the large size of these generic trays requires the use of a substantial quantity of impression material. Furthermore, the practitioner must work quickly to fill all of the tray and to fit the tray properly within the patients mouth before the impression material begins to set. The impression material is formulated to generally provide enough working time to allow this process to be completed, however if filling is accomplished very quickly the patient is left gagging on a mouthful of overflowing aqueous impression material as they wait for the material to harden.

[0016] As can be seen, therefore, the development of a dental impression tray that is inexpensive, space efficient, and does not require large imprecise fitting sidewalls to retain the impression material would overcome numerous drawbacks with impression trays currently in use. The inflatable impression tray in accordance with the present invention satisfies that need, as well as others, and overcomes deficiencies in previously known techniques.

BRIEF SUMMARY OF THE INVENTION

[0017] The present invention generally comprises a dental impression tray that is inflated to achieve a desired level of rigidity and loaded with an unsolidified impression material into which dental structures are temporarily interposed during solidification. In one aspect of the invention, an inflatable impression tray containing flow apertures is filled with impression material which inflates the tray and flows out to build up on the surface into which dental surfaces may be interposed. In one embodiment, the inflatable impression tray has an inflatable member that is configured to provide an impression of the upper left, upper right, lower left and lower right quadrants of the patient.

[0018] According to another aspect of the invention, an impression tray upon which impression material is topically applied is also provided that has internal compartments that may be inflated with a fluid, such as compressed air or water, to provide rigidity to the tray.

[0019] An inflatable tray according to another aspect of the invention provides an inflatable member with flow apertures that has a rigid member to allow efficient insertion into the oral cavity of the patient prior to inflation. In one embodiment, the rigid member is a generally “U” shaped rib disposed on the periphery of the similarly shaped tray. In another embodiment, the rigid member comprises a first rib disposed on the outer periphery of the tray and a second rib disposed on the inner periphery of the tray and substantially parallel to the first rib. In another embodiment, the rigid member comprises a generally “J” shaped rib or wall mounted to the periphery of a quadrant embodiment of an inflatable member. In another embodiment, the rigid member comprises a plurality of floating walls preferably oriented linearly along the periphery of the interior or exterior edges of the legs of the “U” shaped tray.

[0020] The rigid member may be flexible such that the member retains its shape with the removal of force. The rigid member may also be flexible and not retain its original shape after force is applied such as a metal wire. The rigid member may also be inflexible according to the invention.

[0021] According to another aspect of the invention, an inflatable tray is provided that has an inflatable member comprising a mesh or webbing that can shape the impression material and provide a passive framework for the impression material.

[0022] An optional tubular handle or fill tube of varying lengths is provided according to another aspect of the invention. The handle is preferably configured to facilitate the transfer of impression material from a source of material to the inflatable member of the impression tray. In one embodiment, the handle includes a plurality of baffles within the tubular handle that mixes material entering the handle prior to its deposition into the inflatable member of the tray.

[0023] According to yet another aspect of the invention, the impression material and catalyst are mixed prior to deposition in the inflatable dental impression tray with the use of a material mixing tip that is configured to reversibly couple to a fill port in the inflatable member.

[0024] An object of the invention is to provide an inexpensive method of making dental impressions.

[0025] Another object of the invention is to provide a disposable impression tray.

[0026] Another object of the invention is to provide a dental tray capable of being fit to a wide range of patients without sidewall interaction between the tray and the mouth of the patient.

[0027] Another object of the invention is to provide a system of making dental impressions that requires a minimum of impression material to be used per dental impression.

[0028] Another object of the invention is to provide a system of making dental impressions that eliminates the manual loading of the impression tray with impression material.

[0029] Another object of the invention is to provide a system of making dental impressions wherein the impression material is mixed as it enters the tray.

[0030] Another object of the invention is to provide a dental impression system in which the trays take up less space while being stored.

[0031] Still another object of the invention is to provide a dental tray with color indicia and a color scheme that provides a quick indication of the quadrant or type of impression or the purpose of the impression.

[0032] Another object of the invention is to provide an inflatable dental impression tray with chambers or bladders that are capable of being inflated with a liquid, or a gas, such as: impression material, air, water, or gas from a chemical reaction.

[0033] Another object of the invention is to provide a printable dental tray to facilitate identification and private labeling.

[0034] Another object of the invention is to provide a pleasant tasting and/or smelling dental tray for the recipient patient.

[0035] Another object of the invention is to provide impression trays in clear or colors to improve arch or quadrant identification, while preferable providing a location and mechanism by which the patients name may be adhered to the tray.

[0036] Another object of the invention is to provide a dental impression tray that is bondable by either mechanical or chemical adhesion to all dental impression materials.

[0037] Another object of the invention is to provide a tray capable of providing 3 to 50 microns of accuracy.

[0038] Another object of the invention is to provide a system of making dental impressions wherein due to the increased speed of material application, a quicker setting material formulation may be utilized to increase patient comfort and decrease the overall time required for the dental procedure.

[0039] Further objects, aspects and advantages of the invention will be brought out in the following portions of the specification, wherein the detailed description is for the purpose of fully disclosing preferred embodiments of the invention without placing limitations thereon.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0040] The invention will be more fully understood by reference to the following drawings which are for illustrative purposes only:

[0041]FIG. 1 is a perspective view of the inflatable dental tray according to the present invention that has flow apertures for the impression material and a fill tube.

[0042]FIG. 2 is a perspective view of the inflatable dental tray of FIG. 1, shown being filled with impression material from a dual-piston syringe assembly.

[0043]FIG. 3 is a cross-section view of an inflatable dental tray of FIG. 2, having vertical flow-apertures shown becoming fully inflated.

[0044]FIG. 4 is a cross-section view of the inflatable dental tray of FIG. 3, shown with the impression material beginning to flow from the apertures.

[0045]FIG. 5 is a cross-section view of an inflatable dental tray of FIG. 1, having vertical and angled flow-apertures shown becoming fully inflated.

[0046]FIG. 6 is a cross-section view of the inflatable dental tray of FIG. 5, shown with the impression material flowing from the apertures.

[0047]FIG. 7 is a cross-section view of an inflatable dental tray having both upward and downward flow-apertures shown becoming fully inflated.

[0048]FIG. 8 is a cross-section view of the inflatable dental tray of FIG. 7, shown with the impression material beginning to flow upward and downward from apertures to form built-up impression areas.

[0049]FIG. 9 is a perspective view of an inflatable dental tray according to the present invention shown configured for taking an impression of a patient's lower teeth.

[0050]FIG. 10 is a perspective view of an inflatable dental tray quadrant according to the present invention.

[0051]FIG. 11 is a perspective view of the inflatable dental tray according to the present invention that is configured without the attached fill tube of FIG. 1.

[0052]FIG. 12 is a perspective view of a mixing tip according to the present invention that provides mixing of impression material for filling the inflatable dental tray of FIG. 11.

[0053]FIG. 13 is a perspective view of the mixing tip of FIG. 12 connected to a squeeze-handle dispenser for the impression material.

[0054]FIG. 14 is a perspective view of an embodiment of an inflatable dental tray having an inflatable fill tube with cross-wise channeling to improve mixing.

[0055]FIG. 15 is a perspective view of an embodiment of an inflatable dental tray having an inflatable fill tube with lengthwise channeling.

[0056]FIG. 16 is a perspective view of an embodiment of a single-rail inflatable upper dental tray wherein the unsolidified impression material is topically applied.

[0057]FIG. 17 is a perspective view of an embodiment of a dual-rail inflatable lower dental tray wherein the unsolidified impression material is topically applied.

[0058]FIG. 18 is a perspective view of an embodiment of an inflatable dental tray quadrant having a hook-shaped inflating tube wherein the unsolidified impression material is topically applied to a retained membrane.

[0059]FIG. 19 is a perspective view of an embodiment of an inflatable dental tray quadrant having an inflating tube that circumscribes a loop wherein the unsolidified impression material is topically applied to a retained membrane.

[0060]FIG. 20 is a perspective view of an embodiment of an inflatable dental tray quadrant having an inflating tube that circumscribes a loop wherein the unsolidified impression material is topically applied to a retained membrane containing apertures.

[0061]FIG. 21 is a perspective view of an embodiment of an inflatable dental tray quadrant having an inflating tube that circumscribes a loop and contains impression material flow apertures for directing material over the retained membrane.

[0062]FIG. 22 is a perspective view of an embodiment of a self-filling inflatable dental tray having an inflating tube that circumscribes an inner and outer perimeter wherein the unsolidified impression material is topically applied to a retained membrane.

[0063]FIG. 23 is a perspective view of an alternative embodiment of an inflatable dental tray quadrant having a rigid member or rib on the periphery of the inflatable member of the tray.

[0064]FIG. 24 is a perspective view of an alternative embodiment of an inflatable dental tray having a pair of rigid ribs on the periphery of the inflatable member of the tray.

[0065]FIG. 25 is a perspective view of an alternative embodiment of an inflatable dental tray having a floating wall on the periphery of the legs of the inflatable member of the tray.

[0066]FIG. 26 is a perspective view of an alternative embodiment of an inflatable dental tray with two pairs of floating walls on the inner and outer periphery of the legs of the inflatable member of the tray.

[0067]FIG. 27 is a perspective view of an alternative embodiment of an inflatable dental tray having a horizontal base.

[0068]FIG. 28 is an alternative embodiment of the inflatable member having a mesh inflatable member.

[0069]FIG. 29 is an alternative embodiment of the invention with a fill-tube having a foil barrier enclosed sleeve and mixing baffles.

DETAILED DESCRIPTION OF THE INVENTION

[0070] Referring more specifically to the drawings, for illustrative purposes the present invention is embodied in the apparatus generally shown in FIG. 1 through FIG. 29. It will be appreciated that the apparatus may vary as to configuration and as to details of the parts, and that the method may vary as to the specific steps and sequence, without departing from the basic concepts as disclosed herein.

[0071]FIG. 1 an embodiment of an inflatable dental tray 10 is shown having a rigid fill tube 12, also referred to as a mixing tip, attached to a U-shaped impression area 14 that is spanned by a membrane 16. The inflatable tray is shown configured for taking a full arch impression, preferably an upper. It will be appreciated that inflatable trays according to the invention may be manufactured in various shapes and sizes for taking impressions of selected dental regions. Circular apertures 18 are shown distributed on the top of the impression area 14. These apertures allow impression material to exude from the tray as it fills so that a material build-up region can be formed above the surface of the tray for making deep impressions. Impression material entering the inflatable impression area 14 passes through fill tube 12, or mixing tip, containing mixing baffles 20, 22, that thoroughly mix the two components of the impression material before it enters the U-shaped impression area 14 of the tray. The baffles may be oriented at opposing angles as are 20, 22 so that efficient mixing takes place. The constituent components of the impression material may enter the fill tube as separate joined streams, or lamina, of moving material that needs to be properly mixed so that the proper reaction and subsequent solidification of the material will occur. The baffles operate to disrupt laminar flow through the baffles such that the lamina are folded and mixed with one another into a homogeneous stream of mixed material. The fill tube 12 receives the impression material through an injection opening 24 within which a check valve 26 is preferably located to prevent the impression material from leaking out of the fill tube once the fill source has been disconnected. A plurality of optional apertures 28 are located toward the inner portion of the impression tray and angled such that impression material can be directed over the membrane 16. It should be recognized that the inflatable tray of the invention of FIG. 1 is substantially non-rigid, or flaccid, prior to being inflated with impression material, more specifically, it does not require the inner and outer sidewalls for retaining a pool of impression material.

[0072]FIG. 2 shows the inflatable tray 10 of FIG. 1 being filled by a dual-piston syringe 30 containing a two-part impression material through an injection opening 24 of the feed tube 12 containing baffles 20, 22 toward the flow apertures 18 within the impression area 14. The tray shown is a slight variant of that shown in FIG. 1, in that the impression tray does not contain the optional apertures 28 of FIG. 1 encircling the membrane 16. Referring to FIG. 2, the twin-tube syringe is shown by way of example, and it should be appreciated that numerous impression material sources are available, such as pistol-grip syringes. Each syringe barrel 32 a, 32 b contains a constituent component of the impression material, that when mixed quickly solidifies. Upon the application of pressure, the dual-plunger head 34 moves the pistons 36 a, 36 b to displace the two materials 38 a, 38 b through the necked down portions of the syringe 40 a, 40 b and the connector 42 that is attached to the injection opening 24 in the feed tube 12. Preferably the components of the impression material are not allowed to mix while within the body of the syringe and furthermore are prevented from mixing immediately upon entering the fill tube 12, so as to reduce clogging problems that can occur when mixed material remains within the tip of the syringe and hardens.

[0073]FIG. 3 shows a cross-section of the impression area 14 of a tray that has been inflated. The membrane 16 is shown attached between the inflated sides of the U-shaped impression area 14 that is configured with apertures 18. The membrane 16 preferably comprises material of the inflatable tray, and provides limited positional support to the perimeter of the inflatable tray, while it allows material to be built up for taking an impression, which includes the roof of the patient's mouth. The membrane 16 can be provided in various sizes, shapes, and materials. In FIG. 3, the inflatable tray of FIG. 2 is shown during the inflation process prior to the exuding of impression material from the apertures 18. FIG. 4 depicts the inflatable tray of FIG. 2 that has been inflated and further filled so as to create a build-up 44 on the portion of the inflatable tray configured with the flow apertures 18. In FIG. 5, the inflatable tray of FIG. 1, having the additional inward facing apertures 28, is shown during the inflation process prior to the exuding of impression material from the apertures 18, 28. FIG. 6 depicts the inflatable tray of FIG. 5 that has been inflated and further filled so as to create a build-up 44 on the portion of the impression area 14 of the inflatable tray configured with the flow apertures 18, 28 and extending over a portion of the membrane 16. In FIG. 7, an inflatable tray similar to FIG. 2 is shown which has apertures 18 located on both the upper and lower surfaces of the impression area 14 separated by membrane 16. The tray is shown during the inflation process prior to the exuding of impression material from the apertures 18. FIG. 8 depicts the inflatable tray having been inflated and further filled so as to create a build-up 44 both above and below a portion of the inflatable tray, which is configured with the flow apertures 18. It will be appreciated that the above descriptions of flow aperture use is provided by way of example, and that a wide latitude of aperture positioning, sizing, and orientation is anticipated so as to satisfy a variety of impression requirements.

[0074]FIG. 9 depicts an impression tray 50 similar to that of FIG. 1, which is preferably utilized for taking lower full arch impressions of the lower dental surfaces of a patient as it is adapted to provide additional space for the tongue of the patient. The tray comprises a fill-tube 52 leading to an impression area 54 with small interior seams 56. Apertures 58 receive impression material by way of the mixing baffles 60, 62 from the injection opening 64 within which a check valve 66 is located. Use of the inflatable dental tray 50 according to the aforesaid embodiment of the present invention involves filling the tray through the fill tube until the desired amount of impression material is built up above the flow apertures, placing the tray within the mouth of a patient, and having the patient apply biting pressure until the dental surfaces are properly embedded within the impression material. After a few minutes have elapsed, the impression material solidifies and the inflatable tray with the dental impressions may be removed from the mouth of the patient. An inflatable tray according to the invention may also be filled in-situ, (while in the patients mouth) however, this may be a less preferred use as the pattern of teeth bearing down over the tray and the flow apertures could disrupt the even flow of the impression material and the formation of a correct impression. Additionally, it can be more difficult to determine how much impression material to dispense into the inflatable tray when the tray is already within the patient's mouth.

[0075]FIG. 10 depicts an embodiment of a quadrant impression tray 70 that provides for taking an impression on a quarter of the dental surfaces at one time (LR, LL, UR, UL). It will be appreciated that the quadrant sized impression tray may be further reduced in size to allow the taking of an impression over smaller portions of a dental surface. The tray 70 comprises a fill-tube 72 leading to a curved impression area 74 shown here with a small interior seam 76. Apertures 78 receive impression material by way of the mixing baffles 80, 82 from the injection opening 84 within which a check valve 86 is located. It will be appreciated that the impression tray may be formed without exposed seams, such as seam 76, which is being illustrated to clarify a simple method of construction.

[0076]FIG. 11 illustrates an impression tray 90 that does not have a fill tube containing mixing baffles and, therefore, must be filled with fully-mixed impression material. The tray comprises a fill-connection 92 leading to a U-shaped impression area 94 spanned by a membrane 96. Flow apertures 98, 100 provide for distribution of impression material both above the impression area 94 and over the membrane 96 that contains impression retention apertures 102. The fill-connection 92 is shown having a fill opening 104 with a check valve 106. It will be appreciated that a variety of designs exist for constructing anti-backflow valves whereas the check valve 106 is shown by way of example. FIG. 12 is a mixing tip 110 which mixes impression material while it is conveyed from a source to an impression tray. The mixing tip 110 has an outer housing 112 in which internal baffles 114, 116, provide for the mixing of the impression material as it traverses the length of the mixing tip 110 toward a nozzle 118 which is configured for coupling with the fill opening of an inflatable dental tray. The mixing tip 110 receives impression material within an input end 120 having an opening 122 that preferably contains a check valve 124. The baffles 114, 116 within the mixing tip 110 induce a non-laminar movement, or flow, of the material passing through the tube so as to effectively “fold” any lamina within the material into one another. It will be understood that various baffling arrangements may be utilized with similar results. FIG. 13 illustrates the use of mixing tip 110 in connection with a source of impression material 130, exemplified as a pistol-grip dual-piston syringe, which may also be referred to as a “cartridge gun”. The pistol-grip syringe 130 is shown having syringe barrels 132 a, 132 b which each contain a constituent component of the impression material that quickly solidifies when mixed. When the pistol-grip handle 134 is squeezed the pistons 136 a, 136 b move to displace a portion of the material 138 a, 138 b through the necked down portions of the syringe 140 a, 140 b and the connector 142 which is attached to the injection opening 122 of a mixing tip 110. Use of a pistol-grip syringe provides additional leverage and flow control of impression material, although, alternative fluidic displacement devices may be utilized.

[0077] Inflatable dental impression trays according to the invention may be manufactured using a variety of materials and assembly methods that allow for the creation of an inflatable container for the impression material. In general, the inflatable tray 10 of FIG. 1 can be manufactured in a manner similar to that of a plastic bag, wherein two sheets of plastic material are thermally sealed together around their joined periphery by a thermal sealing tool. The material from which the inflatable tray is fabricated should be a flexible and tear resistant material having a thickness of from 2 to 5 mils (0.002-0.005 inches), preferably less than 2 to 3 mils. The inflatable tray may be manufactured from any of numerous alternative material films, such as polymer, polyethylene, polyolefin, polyamides, and polyesters with a preferable molecular weight between 50,000 and 100,000. The material of the inflatable tray may be enhanced by the additions of various chemical agents, such as color additives, odiferous additives, olfactory additives, and antimicrobial additives. Inflatable trays thereby can be produced in various colors, smells, and tastes, while having an increased resistance to microbial contamination. Additionally, the inflatable trays may be imprinted with color coding, sizing information, advertising, trade dress, or additional information such as the name of the patient. It will be appreciated that the invention can be implemented in a variety of ways without departing from the inventive principles.

[0078] The inflatable tray requires a filling mechanism, or connection, so that it may be filled with the impression material. The embodiments described thus far utilize a rigid feed tube having baffles to allow filling the impression tray with fully mixed impression material. However, a variety of material filling connections may be used for this purpose, for example: a rigid tube without mixing baffles, a flexible inflatable feed tube, or a direct connection between the source of mixed impression material and the impression area of the inflatable tray without a length of feed tube. FIG. 14 illustrates an embodiment 150 of an inflatable dental tray that utilizes an inflatable fill tube. The inflatable tray has a U-shaped impression area 152 containing apertures 154 and spanned by membrane 156. Filling of the impression area 152 is accomplished by attaching an impression material source (not shown) to the inflatable fill tube 158 at the necked-down region 160 at opening 162 through which impression material is received from the impression material source to inflate and thereafter exude from the apertures 154 in the impression area 152. The inflatable fill tube may additionally contain baffles for the mixing of the material. Baffles may be exemplified as a criss-cross seam pattern 164 that provides a circuitous snaking path for the two parts of the material which disrupts laminar fluid flow (an effect of abrupt direction and aspect ratio changes) to thereby intermix the impression material as it flows through the fill tube 158. The fill tube 158 may additionally contain a fluid divider 166 that prevents mixing of constituent parts of the impression material near the fluid coupling with the source of the impression material so as to reduce the chances of residual amounts of mixed material hardening within the tip of the impression material source. FIG. 15 is an alternative embodiment 170 of an impression tray having an inflatable fill tube with longitudinal baffles. A U-shaped impression area 172 is shown having apertures 174 and being spanned by a membrane 176. The impression area receives impression material through a fill tube 178 from an opening 180. The components of the impression material are initially retained in separation by divider 182 and then caused to mix with one another within the channels formed by separations 184. It will be appreciated that an inflatable fill tube may be configured with various alternative baffle arrangements without departing from the inventive teachings.

[0079] The impression trays described thus far have been inflated with impression material that was allowed to exit through apertures forming built up areas of impression material. It will be recognized that inflatable trays may also be separately inflated and loaded with impression material. FIG. 16 exemplifies one such embodiment of an inflatable dental tray 190 in which the impression material is applied topically, in a similar manner much like that performed with a typical shell-type tray. This tray is configured preferably for taking upper impressions since it has a membrane 194 across the full span of the inflatable tube 192. An outer perimeter inflatable sidewall 192 is spanned by a membrane 194 and filled through an input 196, which includes a valve (not shown). The tray is filled through the valve at the input 196 with a selected gas or liquid until it becomes sufficiently rigid, whereupon the impression material is applied to one or both sides of the inflatable tray. Tray inflation may be provided by various means, including but not limited to: compressed air, gases, water, and curable materials. FIG. 17 is a U-shaped inflatable impression tray 210 similar to that of FIG. 16, however, it is configured with dual-inflation tubes 212, 214, having a membrane 216 that spans between the tubes and leaves the center portion of the tray open. The dual-inflation tubes are shown fluidly interconnected 218 a, 218 b, 218 c wherein the fluid received at the input 220 is evenly distributed.

[0080] An inflatable impression tray according to the present invention may be implemented in a variety of additional shapes and styles. Another embodiment 230 of FIG. 18 illustrates a hook-shaped quadrant tray wherein an inflation tube 232 is configured in a hook shape with an end 234 and a bend 236. A membrane 238 upon which impression material may be topically applied spans the area between the sides of the inflation tube. The inflation tube 232 has a filler input 240 with a valve 242 to allow for liquid or gas filling to attain sufficient structural rigidity to accept the impression material. An additional quadrant tray 250 is exemplified in FIG. 19 wherein the inflation tube 252 forms a loop with a sharp bend 254 to form a substantially narrow loop which is spanned by a membrane 256 upon which the impression material is to be topically applied. The inflation tube 252 has a filler input 258 with valve 260 providing for liquid or gas filling. FIG. 20 is another example of an impression tray 270 wherein the membrane 276 spanning the loop of the inflation tube 272 is configured with structures, herein depicted as round apertures, to increase adherence between the topically applied impression material and the impression tray. The tray is shown in a narrow quadrant configuration with bend 274, and a filler input 278 containing valve 280. A hybrid approach to a quadrant impression tray 290 is depicted in FIG. 21 wherein an inflatable tube 292 forms a narrow loop with bend 294 which is spanned by a membrane 296 having apertures therein and filled at a filler input 298 containing a valve 300. This impression tray is configured for filling with impression material and is adapted with a plurality of flow apertures 302 along the inflatable tube 292 so that once sufficient impression material is forced into the inflatable tube 292 it will begin to flow from the flow apertures 302 and build up on the membrane 296.

[0081] A self-inflating impression tray may also be manufactured according to the invention wherein external sources of gas or liquid are not required to inflate the tray. FIG. 22 is an embodiment 310 of a self-inflating impression tray upon which impression material may be topically applied. An inflation tube 312 forms a U-shape with two narrow bends 314 a, 314 b spanned by membrane 316 to cover an upper or lower set of dental surfaces. The front 318 of the tray is configured with a pair of compartments 320, 322 containing chemical reactants that react when mixed to generate the requisite amount of gas to inflate the tube at a sufficient pressure. The compartments are bounded by fixed walls 324, 326, and separated by a rupturable membrane 328, which upon rupturing opens up apertures within the walls of the tube 312 to allow filling by the generated gas. It is preferable that the reacting chemicals be non-toxic, an example of which is sodium bicarbonate and citric acid. These reactants are stored in the separate compartments and preferable brought into contact by rupturing a membrane so that the gas created thereafter inflates the tube making the tray rigid. Various additional chemical expansion mechanisms will be well known to those of ordinary skill in the art.

[0082] Turning now to FIG. 23 through FIG. 27, alternative embodiments of the invention can be seen that includes one or more rigid members to support the tray and prevent distortion of the tray during inflation as well as when the patient bites down on the tray.

[0083] Referring specifically to FIG. 23, one embodiment of a quadrant impression tray 330 is shown. The tray 330 generally comprises a fill-tube 332 that is configured to couple with a source of impression material from an injection opening 334, which includes a check valve 336 in this embodiment.

[0084] Impression material is directed through fill-tube 332 and into the interior of the curved impression area of the inflatable member 338 thereby inflating the member. Impression material is extruded through apertures 340 that are present on the upper surface of the inflatable member 338.

[0085] A rigid member 342 such as a rib is mounted on the exterior of the inflatable member 338 and is preferably coupled to the fill tube 332 to provide structural support to the tray 330. It can be seen that the rigid rib 342 provides a general linear orientation to the inflatable member 338 prior to inflation to facilitate the easy placement of the inflatable member 338 of tray 330 in the mouth of the patient. The rigid member 342 may be made from inflexible materials such as plastic, thermoplastic, metal, or ceramic. The rigid member 342 may be made from flexible materials such as rubber, silicones, polyvinyl siloxanes, ethers, foams, paper, wax, foil, nylon fibers, rayon fibers, woven and non-woven natural and man made fibers and the like. The rigid member 342 may also comprise air or water bladders or compartments within the inflatable member 338.

[0086] Rigid member 342 may be mounted to the interior surface, the exterior surface or within the walls of the inflatable member 338. In the embodiment shown in FIG. 23, the rigid member is a coated wire with a “memory” to keep its shape. In another embodiment, the rigid member does not have a memory and will remain be distorted from its original shape if the member is bent.

[0087] One deficiency seen in current impression trays in the art is that the shape of the metal or plastic tray distorts the tissue surrounding the teeth when the patient bites down into the impression material when impression is made. Rigid member 342 is preferably rigid enough to allow placement of the inflatable member 338 and maintain the structure of the inflatable member when inflated without distorting the tissue.

[0088] Referring now to FIG. 24, an alternative embodiment of a full arch impression inflatable tray 344 with two rigid members is shown. The first rigid member 346 is a generally “U” shaped inner member. The second rigid member 348 is a pair of outer curved ribs 348 a, 348 b mounted to collar 356. In the embodiment shown, the inner rigid member 346 has a triangular cross-section that provides a vertical wall on the interior. The interior wall restricts the radial expansion of inflatable member 352 after inflation. Likewise, ribs 348, 350 restrict the outward radial expansion of the inflatable member 352 and assists in directing impression material out of apertures 354 as well as avoiding over inflation of the inflatable member 352.

[0089] Collar 356 may be configured to mate with any existing source of impression material or mixing device including the mixing tip described herein. The collar of the embodiment shown in FIG. 24 has an optional check valve 358 to prevent the impression or other material injected in the tray from leaking out once the source of material is disconnected from the tray.

[0090]FIG. 25 depicts an alternative embodiment of a full arch inflatable tray 360 having a pair of free floating rigid walls along the outer edge of the inflatable member 362 of the tray 360. In the embodiment shown, there is a first floating wall 364 in one leg of the “U” shaped tray and a second floating wall 366 in the other. In one embodiment, walls 364, 366 are capable of folding down flat when the inflatable member 362 is not inflated. When impression material is injected from a source of supply through collar 368 of fill-tube 370, it is mixed by passing baffles 372 and enters the inflatable member 362. As inflatable member 362 inflates, walls 364, 366 move from a generally horizontal position to a generally vertical position. The walls 364, 366 stabilize the tray and inhibit localized bubbling or pressure points in the inflatable member 362 that may occur with viscous impression material as it moves out apertures 374 or as the patient bites down on the tray.

[0091] Referring now to FIG. 26, an alternative embodiment of and inflatable tray 376 is shown with two pairs of floating walls. The left leg of the inflatable member 378 of tray 376 has an inner wall 380 and an outer wall 382. Likewise, the right leg has an inner wall 384 and an outer wall 386. It will be seen that impression material can be injected through collar 388 into feed tube 390 and around optional baffles 392 and into the inflatable member 378 in the embodiment shown. The patient may either bite down on an inflated inflatable member 378 or may bite down on the inflatable member and allow the member 378 and material to inflate around the teeth.

[0092] The alternative embodiment of an inflatable tray 396 is shown in FIG. 27. The tray has a generally horizontal rigid member 398 that is disposed on the bottom side of inflatable member 400 and attached to fill-tube 402 in this embodiment. It will be understood that the rigid member 398 can be a wide sheet covering the width of the inflatable member 400 or a narrow sheet or rib.

[0093] As with previous embodiments, the tray 396 can be inflated with impression material and then the patient bites down on the tray to create the impression. Or, the tray 396 can be placed in the mouth of the patient and impression material injected into collar 404 of fill-tube 402 and through baffles 406 and out apertures 408 to inflate the inflatable member 400 around the dental structures.

[0094] Turning now to FIG. 28, an alternative embodiment of a quadrant inflatable tray 410 with an alternative inflatable member 412 is shown. In this embodiment, the inflatable member 412 generally comprises a mesh or netting of varying pore sizes. This embodiment can be used as an alternative treatment delivery system for fluoride treatments or for tooth bleaching treatments and the like. For example the patient can have the tray 410 placed in the mouth and then bite down gently on the inflatable member 412. Fluoride or whitening agents and the like that is in liquid or gel form may be injected into the inflatable member 410 through collar 414 of fill-tube 416 that expands around the teeth and delivers the treatment. Optional baffles 418 in fill-tube 416 may be used to mix medicines or other materials before it enters the inflatable member 410.

[0095] Other meshes may also be used with impression material in this embodiment as a passive structure to generally form and shape the impression material in the tray. The mesh does not interfere with the formation of the dental impression in this embodiment.

[0096] Various types of impression material can be used with the many embodiments of the inflatable impression tray. Some impression material is slow setting and other material is fast setting. Still other impression material requires the combination of a catalyst with the base material to start the curing of the material. Some impression material is light activated and requires an optically transparent inflatable member. Other impression material or medicine may require the inflatable member to be optically opaque.

[0097] It can be seen that the catalyst could be impregnated in the inflatable member or within the handle such that material passing through will receive the catalyst and polymerize the reaction. In the alternative embodiment 420 show in FIG. 29, the catalyst or medicine is stored in a cylindrical sleeve 422. A first foil barrier 424 at the distal end of the sleeve caps the cylindrical sleeve 422 and a second foil barrier 426 at the proximal end of the sleeve encloses the interior of cylinder 422.

[0098] Cylindrical sleeve 422 is configured to slide over the end of fill-tube 428. Optionally, the outer edge of the fill-tube has a small spike that is capable of puncturing the foil barrier 426. In the embodiment shown in FIG. 29, the cylindrical sleeve can slide down the shaft of fill-tube 428 until the spike or the edge of the fill-tube engages and punctures the foil barrier 426. Fill-tube 428 may also have a stop 430 to restrict the progress of the sleeve 422 down the shaft of tube 428.

[0099] In use, the distal end of cylindrical sleeve 422 would couple with the end of fill tip 432 and foil barrier 424 would be punctured or previously removed. Sleeve 422 would then be advanced on fill-tube 428 to stop 430 thereby puncturing foil barrier 426. Material from the syringe tip 432 along with the material from sleeve 422 will move through fill-tube 428 and be further mixed by baffles 434. The mixed material will then enter inflatable member 436 and out apertures 438 in the embodiment shown. The inflatable member 436 may also have mixing baffles 440 to further mix the materials entering the inflatable member.

[0100] Another embodiment includes an olfactory component in the contents of sleeve 422. Alternatively, the olfactory component may be applied to the tray or included in the composition of the materials of the inflatable tray. The olfactory component provides a pleasant smell to enhance the patient acceptance of the tray and impression material.

[0101] The flavor of the impression material and tray may also be masked with flavors to enhance patient acceptance of the tray during use. An unacceptable taste to the impression material and tray may lead to gagging or removal or grabbing of the tray by the patient before the impression procedure is complete.

[0102] In yet another embodiment of the invention, the apparatus may include indicia that are part of an identification scheme. For example, the inflatable membrane may be color coded to indicate the type of impression or treatment that was taken. Each quadrant of the mouth may be assigned a color so that the practitioner knows which area of the mouth the impression should be taken. Similarly, the top and bottom trays could be assigned a specific color.

[0103] Color coding or other indicia may also be used to indicate the type of procedure to which the tray is associated. For example, bridges may be coded one color, dentures another, and implants a third color. Porcelain or gold crowns, wax ups and diagnostic casts can be coded to provide a quick reference indicator for the practitioner.

[0104] In can also be seen that the impression tray of the present invention can be used for non-human uses such as with canines by veterinarians. Extended trays can be placed in the mouth of an animal and the impression material injected into the inflatable member of the tray and around the dental structures of the animal.

[0105] Accordingly, the use of an inflatable tray as taught herein provides numerous benefits for both dental practitioners and patients. The following are given as additional examples and not as limitations to the practice of the present invention. It should be recognized that the inflatable tray 10 of FIG. 1 and the alternative embodiments described in other figures may be configured for various shapes and sizes to create impressions of portions of the various dental surfaces, some of which have been described. An inflatable tray being filled with impression material may be constructed with apertures for allowing impression material flow out and build up on the outside, however, an inflatable tray may be constructed without the apertures, wherein as the patient bites down on a thin exterior layer so that it ruptures or stretches to conform to the dental structure to create an impression. Inflatable trays with apertures are preferred over the non-aperture trays as they benefit from having additional impression material in the buildup areas and can be filled without trapping air bubbles. Preferably, the inflatable tray, and the impression material that it retains, should become either mechanically or chemically attached to one another to stabilize the finished impression. Various embodiments of the inflatable trays have been exemplified for the present invention which enhance the process of making dental impressions, so that impressions can be created in less time, with more comfort, and at reduced cost.

[0106] Although the description above contains many details, these should not be construed as limiting the scope of the invention but as merely providing illustrations of some of the presently preferred embodiments of this invention. Therefore, it will be appreciated that the scope of the present invention fully encompasses other embodiments which may become obvious to those skilled in the art, and that the scope of the present invention is accordingly to be limited by nothing other than the appended claims, in which reference to an element in the singular is not intended to mean “one and only one” unless explicitly so stated, but rather “one or more.” All structural, chemical, and functional equivalents to the elements of the above-described preferred embodiment that are known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the present claims. Moreover, it is not necessary for a device or method to address each and every problem sought to be solved by the present invention, for it to be encompassed by the present claims. Furthermore, no element, component, or method step in the present disclosure is intended to be dedicated to the public regardless of whether the element, component, or method step is explicitly recited in the claims. No claim element herein is to be construed under the provisions of 35 U.S.C. 112, sixth paragraph, unless the element is expressly recited using the phrase “means for.” 

What is claimed is:
 1. An apparatus for creating a dental impression, comprising: an inflatable base member configured for placement adjacent to a surface in the mouth of a patient; said base member having a plurality of apertures through which material can flow when injected into said base member; and a rigid retaining member supporting said inflatable base member.
 2. An apparatus as recited in claim 1, further comprising: a fill tube attached to said base member; said fill tube having a plurality of internal baffles configured for mixing impression material components as said components flow through said fill tube and into said base member.
 3. An apparatus as recited in claim 1, wherein said rigid retaining member comprises a plurality of flexible ribs positioned at the periphery of said inflatable base member.
 4. An apparatus as recited in claim 1, wherein said rigid retaining member comprises a coated wire positioned at the periphery of said inflatable base member.
 5. An apparatus as recited in claim 4, wherein said wire is resilient.
 6. An apparatus as recited in claim 1, wherein said rigid retaining member comprises a generally vertical wall positioned at the periphery of said inflatable base member.
 7. An apparatus as recited in claim 1, wherein said rigid retaining member comprises a pair of substantially parallel walls.
 8. An apparatus as recited in claim 1, further comprising: a collar coupled to said base member; said collar dimensioned to engage said means for injecting material into said base member, wherein material can be easily injected into said base member.
 9. An apparatus as recited in claim 8, wherein at least one rigid retaining member is mounted to said collar.
 10. An apparatus as recited in claim 1, further comprising means for preventing the release of material from an inlet to said base member after said inlet is disconnected from said means for injecting material into said base member.
 11. An apparatus as recited in claim 10, wherein said means for preventing release of material comprises a check valve.
 12. An apparatus as recited in claim 1, wherein the base member in an uninflated state is substantially planar.
 13. An apparatus as recited in claim 1, wherein said injected material comprises dental impression material.
 14. An apparatus as recited in claim 13, wherein said base member further comprises: a plurality of baffles within said base member, wherein a laminar flow of injected impression material is disrupted by said baffles.
 15. An apparatus as recited in claim 13, wherein said base member further comprises: a layer of impression material catalyst within said base member.
 16. An apparatus as recited in claim 13, further comprising: a light sensitive catalyst mixed with said impression material; wherein said base member is configured to transmit light from the exterior of the base to the interior of the base.
 17. An apparatus as recited in claim 13, further comprising: a light sensitive catalyst mixed with said impression material wherein a reaction catalyzed by said catalyst in said impression substantially ceases after injection of said impression material in said base member; wherein said base member is configured to be optically opaque from the exterior of the base to the interior of the base.
 18. An apparatus as recited in claim 13, wherein said impression material further comprises: an olfactory additive, wherein the scent of said impression material is acceptable to the patient.
 19. An apparatus as recited in claim 13, wherein said impression material further comprises: a flavor additive, wherein the taste of said impression material is acceptable to the patient.
 20. An apparatus as recited in claim 13, further comprising color indicia, wherein said color indicia are associated with a type of dental impression.
 21. An apparatus as recited in claim 2, further comprising: a tubular handle coupled to said base member; a source of impression material in fluid communication with said tubular handle; a reservoir associated with said tubular handle, said reservoir containing a catalyst; a barrier dividing said reservoir from said source of impression material, wherein breach of said barrier allows the contents of the source of impression material and of said reservoir to be mixed; and means for breaching said barrier.
 22. An apparatus as recited in claim 21, wherein said barrier comprises a foil sheet.
 23. An apparatus as recited in claim 22, wherein said means for breaching said barrier comprises a prong.
 24. An apparatus as recited in claim 21, further comprising: means for mixing said impression material and said catalyst within said tubular handle.
 25. An apparatus as recited in claim 24: wherein said means for mixing said impression material and said catalyst comprises a plurality of internal baffles configured for mixing impression material and catalyst components as said components flow through said tubular handle and into said base member.
 26. An apparatus as recited in claim 24, further comprising: means for mixing said impression material and said catalyst within said base inflatable member.
 27. An apparatus as recited in claim 26, wherein said means for mixing said impression material within said base inflatable member comprises a plurality of internal baffles mounted to said rigid retaining member configured for mixing impression material and catalyst components as said components flow through said inflatable base member.
 28. An apparatus for creating a dental impression, comprising: an inflatable base member configured for placement adjacent to a surface in the mouth of a patient; said base member having a plurality of apertures through which material can flow when injected into said base member; a tubular handle coupled to said base member; a source of a first material in fluid communication with said tubular handle; and a source of a second material in fluid communication with said tubular handle.
 29. An apparatus as recited in claim 28, further comprising: means for mixing said first material with said second material.
 30. An apparatus as recited in claim 29, wherein said means for mixing said first and second materials comprised a plurality of internal baffles within said tubular handle configured for mixing impression material components as said components flow through said tubular handle and into said base member.
 31. An apparatus as recited in claim 28, wherein said source of first material comprises a material injector coupled with said tubular handle.
 32. An apparatus as recited in claim 28, wherein said source of a second material comprises a reservoir associated with said tubular handle, said reservoir containing said second material.
 33. An apparatus as recited in claim 32, further comprising: a barrier dividing said reservoir of a second material from said source of first material, wherein breach of said barrier allows the contents of the source of impression material and of said reservoir to be mixed.
 34. An apparatus as recited in claim 33, further comprising: means for breaching said barrier.
 35. An apparatus as recited in claim 33, wherein said means for breaching said barrier comprises a prong.
 36. An apparatus as recited in claim 28, further comprising: at least one rigid retaining member supporting said inflatable base member.
 37. An apparatus as recited in claim 36, wherein said rigid retaining member comprises a plurality of flexible ribs positioned at the periphery of said inflatable base member.
 38. An apparatus as recited in claim 36, wherein said rigid retaining member comprises a coated wire positioned at the periphery of said inflatable base member.
 39. An apparatus as recited in claim 38, wherein said wire is resilient.
 40. An apparatus as recited in claim 36, wherein said rigid retaining member comprises a generally vertical wall positioned at the periphery of said inflatable base member.
 41. An apparatus as recited in claim 36, wherein said rigid retaining member comprises a pair of substantially parallel walls.
 42. An apparatus as recited in claim 36, wherein at least one rigid retaining member is mounted to said tubular handle.
 43. An apparatus as recited in claim 36, further comprising means for preventing the release of material from an inlet to said base member after said inlet is disconnected from said means for injecting material into said base member.
 44. An apparatus as recited in claim 43, wherein said means for preventing release of material comprises a check valve.
 45. An apparatus for delivering dental treatment, comprising: an inflatable base member configured for placement adjacent to a surface in the mouth of a patient; said base member having a weave of fibers through which treatment material can flow when injected into said base member.
 46. An apparatus as recited in claim 45, wherein said treatment material comprises a fluoride treatment.
 47. An apparatus as recited in claim 45, wherein said treatment material comprises a dental bleaching treatment.
 48. An apparatus as recited in claim 45, further comprising a fill tube attached to said base member,
 49. An apparatus as recited in claim 48, said fill tube further comprising: a plurality of internal baffles configured for mixing treatment material components as said components flow through said fill tube and into said base member.
 50. An apparatus as recited in claim 48, said fill tube further comprising: a rigid retaining member supporting said inflatable base member.
 51. An apparatus as recited in claim 50, wherein said rigid retaining member comprises a plurality of flexible ribs positioned at the periphery of said inflatable base member.
 52. An apparatus as recited in claim 50, wherein said rigid retaining member comprises a coated wire positioned at the periphery of said inflatable base member.
 53. An apparatus as recited in claim 52, wherein said wire is resilient.
 54. An apparatus as recited in claim 50, wherein said rigid retaining member comprises a generally vertical wall positioned at the periphery of said inflatable base member.
 55. An apparatus as recited in claim 50, wherein said rigid retaining member comprises a pair of substantially parallel walls.
 56. An apparatus as recited in claim 50, further comprising a collar coupled to said base member, said collar dimensioned to engage said means for injecting material into said base member, wherein material can be easily injected into said base member.
 57. An apparatus as recited in claim 56, wherein at least one rigid retaining member is mounted to said collar.
 58. An apparatus as recited in claim 50, further comprising means for preventing the release of material from an inlet to said base member after said inlet is disconnected from said means for injecting material into said base member.
 59. An apparatus as recited in claim 58, wherein said means for preventing release of material comprises a check valve.
 60. An apparatus for creating a dental impression, comprising: an inflatable base member configured for placement adjacent to a surface in the mouth of a patient; said base member having a plurality of apertures through which impression material can flow when injected into said base member; a fill tube fluidly coupled to said inflatable base; a plurality of retaining members supporting said inflatable base member; said retaining members mounted to said fill tube; means for injecting a plurality of materials into said fill tube; and means for mixing said plurality of materials injected into said fill tube.
 61. An apparatus as recited in claim 60, wherein said means for injecting material into said fill tube comprises a syringe.
 62. An apparatus as recited in claim 60, wherein said means for mixing injected materials comprise a plurality of internal baffles configured for mixing impression material components as said components flow through said fill tube and into said base member.
 63. An apparatus as recited in claim 60, wherein said means for mixing injected materials comprise a plurality of internal baffles within said base inflatable member.
 64. An apparatus as recited in claim 60, wherein said retaining member comprises a plurality of flexible ribs positioned at the periphery of said inflatable base member.
 65. An apparatus as recited in claim 60, wherein said rigid retaining member comprises coated wires positioned at the periphery of said inflatable base member.
 66. An apparatus as recited in claim 65, wherein said wire is resilient.
 67. An apparatus as recited in claim 60, wherein said rigid retaining member comprises a generally vertical wall positioned at the periphery of said inflatable base member.
 68. An apparatus as recited in claim 60, wherein said rigid retaining member comprises a pair of substantially parallel walls.
 69. An apparatus as recited in claim 60, further comprising means for preventing the release of material from an inlet to said base member after said inlet is disconnected from said means for injecting material into said base member.
 70. An apparatus as recited in claim 69, wherein said means for preventing release of material comprises a check valve. 